Core Insights - Quantum BioPharma Ltd. has appointed Dr. Jack Antel as a new clinical advisor for its multiple sclerosis program, Lucid-MS, which is designed to inhibit demyelination in MS [1][4][5] - Dr. Antel is a prominent clinical neurologist and expert in MS, with extensive experience and numerous publications in the field [2] - The company aims to advance Lucid-MS into a Phase 2 clinical trial to assess its efficacy in MS patients [4] Company Overview - Quantum BioPharma is focused on developing innovative biopharmaceutical solutions for neurodegenerative and metabolic disorders, including alcohol misuse [8][9] - The company’s lead compound, Lucid-MS, is a patented new chemical entity that has shown potential in preventing and reversing myelin degradation in preclinical models [9] - Quantum BioPharma retains a 20.10% ownership stake in Unbuzzd Wellness Inc., which is associated with royalty payments from sales of the unbuzzd™ product [9]

Core Insights - Immunic Inc is developing vidofludimus calcium, a first-in-class oral medication aimed at treating multiple sclerosis (MS) by addressing both inflammatory flares and neurodegeneration [2][22] - The drug combines two mechanisms: inhibition of the enzyme DHODH to reduce relapses and MRI lesions, and activation of the Nurr1 protein to protect neurons from degeneration [3][9] Drug Mechanism - Vidofludimus calcium targets inflammation by inhibiting DHODH, which helps reduce hyperactivated immune cells responsible for relapses and inflammatory brain lesions [6][7] - The neuroprotective aspect involves activating Nurr1, which is linked to nerve survival and the regulation of microglia, the guardians of the central nervous system [8][9] Clinical Trials and Efficacy - In the EMPhASIS Phase 2 trial, vidofludimus calcium demonstrated a 71%-78% reduction in certain lesion measures over 24 weeks and a significant reduction in disability worsening [10][11] - The CALLIPER Phase 2 study showed a 24% reduction in the risk of confirmed disability worsening in the overall population, with a 31% reduction in primary progressive MS patients [12][13] Market Potential - The fully de-risked market for vidofludimus calcium is estimated to be between $3 billion and $7 billion, indicating significant commercial potential [20] - The company raised $65 million in an oversubscribed funding round, reinforcing investor confidence [20] Future Developments - Two global Phase 3 trials, ENSURE-1 and ENSURE-2, have completed enrollment, with results expected by the end of 2026 [14][19] - The company is engaging with regulators to discuss the potential for a Phase 3 study, particularly in primary progressive MS [20][22]

Core Insights - Novartis announced new data on Kesimpta® (ofatumumab) for relapsing multiple sclerosis (RMS) to be presented at ECTRIMS 2025 Annual Meeting [1] - The studies demonstrate significant efficacy and safety of Kesimpta in patients who switched from other therapies [2][3] Study Findings - The ARTIOS Phase IIIb study showed a low annualized relapse rate (ARR) of 0.06 over 96 weeks for patients switching to Kesimpta, with over 90% achieving no evidence of disease activity (NEDA-3) [2][6] - The ALITHIOS study indicated that more than 90% of recently diagnosed treatment-naïve patients achieved NEDA-3 at seven years, highlighting long-term efficacy [3][6] Safety Profile - No new safety concerns were reported in both studies after switching to Kesimpta, reinforcing its favorable safety profile [2][3] Product Overview - Kesimpta is a targeted B-cell therapy administered via subcutaneous injection, approved in over 92 countries, with more than 150,000 patients treated as of August 2025 [5][6] Company Background - Novartis has over 80 years of experience in tackling neurological conditions and continues to develop transformative treatments in multiple sclerosis and other neurological diseases [7]

Core Insights - Novartis announced new data on Kesimpta (ofatumumab) for relapsing multiple sclerosis (RMS) at the ECTRIMS 2025 Annual Meeting, highlighting its efficacy and safety in patients who switched from other therapies [1][2][3] Study Findings - The ARTIOS Phase IIIb study demonstrated a low annualized relapse rate (ARR) of 0.06 over 96 weeks for patients switching to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies, with over 90% achieving no evidence of disease activity (NEDA-3) [2][6] - The ALITHIOS extension study showed that more than 90% of recently diagnosed treatment-naïve patients on first-line Kesimpta maintained NEDA-3 status at seven years, indicating long-term efficacy [3][6] Safety Profile - No new safety concerns were reported in both studies following the switch to Kesimpta, reinforcing its favorable safety profile [2][3][4] Product Information - Kesimpta is a targeted B-cell therapy administered via subcutaneous injection, approved in over 92 countries, with more than 150,000 patients treated as of August 2025 [5][6] Company Background - Novartis has over 80 years of experience in tackling neurological conditions and continues to develop transformative treatments in multiple sclerosis and other neurological diseases [7]

Core Insights - Roche presents new data for OCREVUS and fenebrutinib at ECTRIMS 2025, highlighting significant advancements in multiple sclerosis treatment [1][2][3] Group 1: OCREVUS Efficacy and Safety - OCREVUS shows significant benefits in preventing disability progression in various MS patient groups, including children and pregnant women [2][3] - Phase III data confirm that OCREVUS maintains a consistent benefit-risk profile for up to two years, with near-complete suppression of relapses and disability progression [4][8] - In the ORATORIO-HAND study, OCREVUS demonstrated a 30% reduction in the risk of 12-week composite confirmed disability progression in advanced PPMS patients compared to placebo [6][9] Group 2: Fenebrutinib Development - Phase II data for fenebrutinib indicate near-complete suppression of disease activity at 96 weeks, with ongoing Phase III trials [14][15] - Fenebrutinib is designed to address unmet medical needs in MS by inhibiting both B-cell and microglia activation [19] Group 3: Pediatric and Pregnancy Outcomes - Data from the ocrelizumab pregnancy registry show no increased risk of adverse pregnancy or infant outcomes with OCREVUS exposure [10][11] - Infants exposed to OCREVUS during pregnancy or breastfeeding exhibited strong antibody responses to vaccines, indicating effective immune recognition [11][12] Group 4: Research and Development Focus - Roche is committed to advancing neuroscience research, with over a dozen medicines under investigation for neurological disorders, including multiple sclerosis [22][23]

Core Insights - TG Therapeutics, Inc. announced the schedule for presentations on BRIUMVI (ublituximab-xiiy) data for patients with relapsing forms of multiple sclerosis (RMS) at the 2025 ECTRIMS annual meeting in Barcelona, Spain [1][2] Presentation Details - An oral presentation will cover the long-term efficacy and safety of ublituximab based on six years of data from the ULTIMATE I and II open-label extension studies [2] - ePoster presentations will include updates on a modified dosing regimen from the ENHANCE study and real-world clinical experiences from the ENABLE Phase 4 observational study [2] Clinical Trials Overview - The ULTIMATE I & II trials are randomized, double-blind, and active comparator-controlled studies involving 1,094 patients with RMS across 10 countries, treated for 96 weeks [3] - Patients were randomized to receive either BRIUMVI or teriflunomide, with specific dosing regimens outlined for both treatments [3] Product Information - BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, designed to enhance B-cell depletion at lower doses through glycoengineering [4][5] - It is approved in the U.S. and Europe for treating adults with RMS, including various forms of the disease [5][26] Safety and Efficacy Data - The incidence of infusion reactions in BRIUMVI-treated patients was reported at 48%, with serious reactions occurring in 0.6% of patients [7] - The overall infection rate in BRIUMVI-treated patients was 56%, with serious infections at 5% [9] Company Background - TG Therapeutics is focused on developing and commercializing treatments for B-cell diseases, with BRIUMVI being a key product in their portfolio [26]

Company Overview - Immunic Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral therapies for chronic inflammatory and autoimmune diseases[5] - The company's lead drug candidate, Vidofludimus Calcium, has a peak sales potential of $3-7 billion in Multiple Sclerosis (MS)[5] - As of June 30, 2025, Immunic had a cash balance of $55.3 million[5] Clinical Pipeline - Vidofludimus Calcium's Phase 2 EMPhASIS trial in Relapsing-Remitting Multiple Sclerosis (RRMS) was successfully completed, showing a reduction in disability worsening[6] - The CALLIPER trial for Progressive Multiple Sclerosis (PMS) with Vidofludimus Calcium also showed substantial reductions in disability worsening[6] - Top-line data for the ENSURE trials (ENSURE-1 and ENSURE-2) in Relapsing Multiple Sclerosis (RMS) are expected by the end of 2026[6] Vidofludimus Calcium Efficacy - The EMPhASIS trial showed a 78% reduction in cumulative unique active (CUA) lesions and a 74% reduction in Gadolinium-enhancing (Gd+) lesions with the 45mg dose compared to placebo[44] - In the CALLIPER trial, Vidofludimus Calcium demonstrated a 24% risk reduction of 24-week confirmed disability worsening (24wCDW) in the overall study population[94] - A 34% reduction of 24wCDW was observed in patients without baseline inflammatory lesions in the CALLIPER trial[95] Market Opportunity - The Multiple Sclerosis (MS) market is large and growing, with many brands generating over $1 billion in global annual sales in 2024[100] - The MS therapies market is currently a $20 billion market growing at 4% year-over-year[101] - Vidofludimus Calcium has a potential peak sales of $1-2 billion for Relapsing MS (RMS), $1-2 billion for non-active Secondary Progressive MS (naSPMS), and $2-3 billion for Primary Progressive MS (PPMS)[108]

Core Insights - Immunic Inc's CEO Dr. Daniel Vitt highlighted the promising results from the Phase 2 CALLIPER trial of vidofludimus calcium, showing a 24% reduction in disability progression across the full study population, with over 30% reduction in patients with primary progressive MS [1][2]. Clinical Progress - The CALLIPER study aimed to analyze the neuroprotective effect of vidofludimus calcium in patients with progressive forms of multiple sclerosis, addressing a significant unmet medical need [2]. - The CALLIPER data is deemed important for various forms of MS, including primary progressive, secondary progressive, and relapsing MS, with ongoing Phase 3 ENSURE studies expected to benefit from the drug's neuroprotective features [3]. Trial Enrollment and Milestones - The company completed enrollment for both ENSURE trials, involving a total of 2,200 patients, marking a significant milestone in the quarter [4]. - The trials are set to read out next year, indicating a step closer to potential new treatment options for patients with relapsing MS [4]. EMPhASIS Trial Results - New data from the Phase 2 EMPhASIS trial indicated that over 90% of patients treated with vidofludimus calcium for 144 weeks were free of disability progression, showcasing the drug's effectiveness [6]. Financial Position - The company strengthened its balance sheet through two financings, positioning itself well to advance its clinical trials, particularly the Phase 3 studies in relapsing MS [7][8].

Core Insights - Immunic, Inc. has made significant clinical advancements with its lead asset, vidofludimus calcium, particularly in multiple sclerosis treatment, showing promising results in various trials [2][11] - The company has completed enrollment for its phase 3 ENSURE trials, with top-line data expected by the end of 2026, indicating progress towards a potential new treatment option for relapsing multiple sclerosis [2][11] - Financially, Immunic has strengthened its balance sheet with two financings totaling $70.1 million in gross proceeds, although it reported a net loss of approximately $27 million for the second quarter of 2025 [6][9] Clinical Developments - The phase 2 CALLIPER trial demonstrated a 23.8% reduction in time to 24-week confirmed disability worsening in the overall progressive multiple sclerosis population compared to placebo, with even higher reductions in specific subgroups [2][7] - Long-term open-label extension data from the phase 2 EMPhASIS trial showed that 92.3% of patients remained free of 12-week confirmed disability worsening at week 144, reinforcing the drug's efficacy [2][6] - Vidofludimus calcium's neuroprotective effects are believed to be mediated through activation of the Nurr1 target, which may address the complex pathophysiology of multiple sclerosis [2][11] Financial Performance - Research and Development (R&D) expenses for the second quarter of 2025 were $21.4 million, an increase from $18.3 million in the same period of 2024, primarily due to higher external development costs related to vidofludimus calcium [6][8] - General and Administrative (G&A) expenses also increased to $5.7 million for the second quarter of 2025, compared to $4.5 million in the prior year [8] - The company reported a net loss of approximately $27 million for the second quarter of 2025, with a net loss per share of $0.20, reflecting a slight improvement from a net loss of $21.4 million in the same quarter of 2024 [9][14] Market Potential - The market for primary progressive multiple sclerosis is estimated to exceed $6 billion, with vidofludimus calcium positioned as a promising treatment option in this underserved area [2][11] - The company is also preparing for further clinical testing of IMU-856, which targets gastrointestinal disorders and may offer a novel therapeutic approach [3][4]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was reported at $141.1 million, which includes U.S. net product revenue of $138.8 million, representing a 91% increase compared to the same period last year and a 16% growth over Q1 2025 [21][22] - GAAP net income for the quarter was $28.2 million, or $0.17 per diluted share, compared to $6.9 million, or $0.04 per diluted share, for Q2 2024 [23] Business Line Data and Key Metrics Changes - The flagship product, BREONVY, generated net sales of approximately $139 million in Q2 2025, exceeding internal expectations and building on robust growth from Q1 [14] - The adoption rate of BREONVY is estimated at nearly one in every three new IV anti-CD20 patients, indicating significant market penetration [7] Market Data and Key Metrics Changes - The CD20 class generates over $8 billion in annual U.S. MS sales, with BREONVY steadily increasing its market share within this expanding market [15] - The company is focused on expanding its addressable market by developing a subcutaneous formulation of BREONVY, which could unlock access to 35% to 40% of the anti-CD20 market segment that prefers self-administered options [8] Company Strategy and Development Direction - The company aims to position BREONVY as the most prescribed anti-CD20 therapy for relapsing MS, with ongoing efforts to enhance patient experience and expand treatment options [6][11] - A national television campaign has been launched to increase patient awareness, with early signs indicating a positive impact on brand recognition [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth for BREONVY, raising full-year U.S. revenue guidance to $560 million to $575 million for 2025 [19] - The company anticipates stronger growth from Q3 to Q4, accounting for seasonal trends and increased patient enrollments [27] Other Important Information - The company reported total operating expenses of approximately $71 million for Q2 2025, an increase from $46.9 million in 2024, driven by R&D investments [22][23] - The company closed the quarter with approximately $279 million in cash and equivalents, maintaining a strong capital position for future investments [24] Q&A Session Summary Question: Guidance and Growth Expectations - Management acknowledged seasonality in summer and expects stronger growth from Q3 to Q4, which is reflected in the raised guidance [26][27] Question: Market Dynamics and Competitors - The company captures about one-third of the IV segment, with competitors sharing the remaining market [31] - There are no current signs of demand for subcutaneous options outpacing IV, but the company is actively developing its own subcutaneous formulation [32] Question: Subcutaneous Product Development - The subcutaneous product will initially be tested with a syringe from a vial, followed by a bridging study to an auto-injector [36] Question: Revenue Guidance and Market Trends - Management noted that the overall IV market is stable, with limited enthusiasm for competitor products [43][44] Question: Product Adherence and Q3 Guidance - The company did not provide specific Q3 guidance but indicated strong persistence rates for BREONVY [54][55]